EO Residual Testing
Ethylene oxide (EO) is a gas used for sterilization of many products. Residuals of the EO gas remain on a product following sterilization. While a highly effective sterilization agent, EO is toxic to the human body at certain levels. EO residual testing assesses the amount of EO and ethylene cholorohydrin (ECH) residuals remaining on a product, following EO sterilization, and evaluates whether the EO residuals remaining meet the EO residual testing limits for the intended device use.
Our Tests
B200
EO, ECH, EG, (water extraction) Simulated Use ANSI/AAMI/ISO, one sample
B200A
EO, ECH, EG, (water extraction) Simulated Use ANSI/AAMI/ISO, multiple samples, each
B201
EO, ECH, Exhaustive subsequent extraction to <10% of first extraction
B202
EO, Exhaustive Extraction, Thermal Head-Space Analysis, per sample
B203
ECH (only) water extraction
B204
EO (only) water extraction
B205
EG (only) water extraction
B206
EO, ECH, EG Device
B207
EO, ECH, EG for liquid samples
B208
Evaluation of Overlapping/Interfering peaks
B210
Establishment of Dissipation Curve
Sample Submission
Purchase Order
In line with current ISO/QSR purchasing requirements, all orders should be sent with a signed completed Purchase Order. This will help expedite the processing or your order. Standing Purchase Orders will be gladly accepted for routine continuing orders.
Sample Submission Form
Please download and fill out a Test Request Form for each sample/test submitted. Identify each submission clearly and completely. Please be specific with the description, Lot Number, PO etc. and specify the test desired. Please indicate the Test Code Number on the form also. This will greatly reduce turnaround time necessary to generate an accurate, final report.
Final Reports
Upon completion of test, a final report will be issued and all records and raw data will be held for five years.
How To Calculate Allowable Limits For Ethylene Oxide Sterilization
Learn what ethylene oxide residuals are and how to calculate allowable limits for EtO-sterilization of medical devices and products.
Tolerable Exposure Limits For Ethylene Oxide Sterilized Medical Devices
Learn about ethylene oxide residuals and how to calculate tolerable exposure limits for EtO-sterilized medical devices and products.
How To Calculate Tolerable Contact Limits For Ethylene Oxide
Learn what ethylene oxide residuals are and how to calculate tolerable contact limits for EtO-sterilized medical devices and products.